ClaimIt 2020 1.9

ClaimIt 2020 is an innovative proprietary platform developed by ObvioHealth, designed to facilitate clinical trials through a fully digital and mobile interface. This platform eliminates the need for traditional, resource-intensive site visits by bringing the trial directly to participants' mobile devices.

The deployment of ClaimIt 2020 aims to enhance data integrity, improve participant adherence, accelerate study timelines, and reduce costs—achieving an approximate 50% reduction compared to conventional on-site trials.

Subject Onboarding Process:

• Recruitment via Targeted Landing Page: Utilizes precisely targeted social media campaigns to efficiently direct potential participants to dedicated trial pages, which provide comprehensive information about the study parameters, participant benefits, and compensation details.
• Screening Questionnaire: Interested individuals complete an initial screening survey that automatically assesses eligibility based on predefined inclusion criteria. Ineligible candidates are encouraged to join a database for future recruitment opportunities.
• App Download and Validation: Eligible candidates may be contacted by study staff for response validation and eligibility confirmation prior to being invited to install the ClaimIt 2020 application.

Informed Consent Procedure:

• Participants create a secure account within the platform and proceed through a digital consent process that explicates key study details including privacy policies, data handling practices, task expectations, time commitments, and withdrawal options.
• Opportunities are provided for participants to consult with study personnel before finalizing consent.

Participant Compensation and Product Receipt:

• Participants link a PayPal account within the app to receive milestone-based payments that incentivize study completion.
• Initial delivery involves a mailed package containing necessary devices and products. Participants confirm receipt of contents via photograph submission.

Device Integration and Data Collection:

• The platform supports linkage with various health monitoring devices such as Apple Watch, Fitbit, Bluetooth-enabled scales, blood pressure monitors, and mHealth applications for automated data capture.

Ongoing Engagement During Intervention:

• Daily Tasks include:
• Completion of questionnaires and electronic case report forms (eCRFs) to provide ongoing data inputs.
• Utilization of the app’s camera feature to document product interactions and confirm dosage adherence through image capture.
• Scheduling and tracking of laboratory visits or virtual consultations via an integrated study calendar.
• Participation in online face-to-face video calls or secure messaging with the study team for necessary support and clarification.